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FDA 510(k)

FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT

K-Number: K000471 · 2000-04-11

ApplicantFuture Diagnostics B.V.
Decision Date2000-04-11
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Future Diagnostics B.V.. It received FDA 510(k) clearance on 2000-04-11 under 510(k) number K000471. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT?

FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT is a medical device that received FDA 510(k) clearance on 2000-04-11. The listed applicant is Future Diagnostics B.V.. The 510(k) number is K000471.

When did FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT receive FDA 510(k) clearance?

FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT received FDA 510(k) clearance on 2000-04-11, under 510(k) number K000471.

Who is the listed applicant for FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT?

The FDA 510(k) record lists Future Diagnostics B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT?

The FDA product code for FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT is CEW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Future Diagnostics B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K002638FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT

Related Devices (Code: CEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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